FDAFDA · Food and drugs·Recall number D-1388-2019
Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1
Published June 26, 2019 · Recall initiated: June 5, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot GKT0791, EXP 06/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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